NEW YORK (GenomeWeb) – Dutch genetic testing firm Genome Diagnostics (GenDx) announced on Tuesday that it has CE-IVD registered its line of chimerism monitoring products for use in stem cell or bone marrow transplantation.
The in vitro diagnostic products include the company's KMRtype and KMRtrack reagents and its KMRengine workflow-management and data-analysis software. The KMRtype reagent is used to select informative genetic markers for donor-recipient pairs, the KMRtrack reagent is subsequently used to monitor the markers over time, and the KMRengine software guides the workflow in the lab and analyzes the data, the company said.
GenDx noted that the workflow can be performed on several real-time PCR platforms and has been validated on Thermo Fisher Scientific's ABI7500 and QuantStudio systems. The firm also recently signed an agreement to become a global reseller for Thermo Fisher's Applied Biosystems QuantStudio PCR systems, including the QuantStudio 5, QuantStudio 6 Flex, and QuantStudio 7 Flex.
"We have worked really hard to improve and validate our real-time PCR reagents and software package and are thrilled that we have realized the design goals and the CE-IVD registration," GenDx CEO Wietse Mulder said in a statement. "This set of diagnostic tools advances accurate chimerism monitoring of transplant patients and supports timely intervention when needed."
In early 2016, GenDx received CE-IVD certification for its NGSengine software for analyzing human leukocyte antigen typing in transplant recipients via next-generation sequencing.